ETEST® Meropenem/Vaborbactam (MEV)

GUDID 03573026560690

ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria

BIOMERIEUX SA

Antibacterial minimum inhibitory concentration (MIC) IVD

• Primary Device ID: 03573026560690
• NIH Device Record Key: 4db0d644-1d50-4b8d-9788-b58021f2e0e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ETEST® Meropenem/Vaborbactam (MEV)
• Version Model Number: ETEST® Meropenem/Vaborbactam (MEV)
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026560690 [Package]; Contains: 03573026563578; Package: [30 Units]; In Commercial Distribution
GS1	03573026563578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183031

FDA Product Code

• JWY: Manual antimicrobial susceptibility test systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-04-15
• Device Publish Date: 2019-03-06

On-Brand Devices [ETEST® Meropenem/Vaborbactam (MEV)]

• 03573026623739: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026560690: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of